Understanding cardiac safety early is critical in drug development. In their latest poster, Jazz Pharmaceuticals, explain how they utilised Metrion’s clinically translatable cardiotoxicity assay to do exactly that.
The recently released ICH E14/S7B 2022 Q&As provides the best practice guidelines for evaluating the effect of preclinical compounds on the human ether-à-go-go-related gene (hERG) potassium channel1. The guidelines stipulate that in vitro hERG assessments should be performed to GLP compliance. In addition, it provides recommendations on the experimental methods that should be employed, the quality control parameters for analysing the data, as well as the preferred format for reporting the data. This is to ensure data quality, transparency and consistency throughout the industry. A hERG assay is considered negative if the safety margin calculated for the test article is greater than the established safety margins generated with the FDA’s positive controls (ondansetron, moxifloxacin and dofetilide) tested to the best practice guidelines. Metrion conducted a GLP compliant study using the conventional manual patch-clamp technique in accordance with the ICH E14/S7B Q&A best practice guidelines to establish in-house IC50 values for ondansetron, moxifloxacin and dofetilide.
Understanding cardiac safety early is critical in drug development. In their latest poster, Jazz Pharmaceuticals, explain how they utilised Metrion’s clinically translatable cardiotoxicity assay to do exactly that.
Development of a robust hNaV1.9 high-throughput screening assay on the Sophion Qube384 platform. This is complemented by a suite of ion channel selectivity assays and sensory neuron recordings to create a versatile screening cascade to support NaV1.9 drug discovery programmes.